> See specialized channels
Medical Devices & Diagnostics
> See specialized channels
> See specialized channels

  Join us

  Follow us on Twitter   Join our LinkedIn Group   Our Blog

Biotech News App
Provides access to the latest biotech press releases ...more

Android_Logo App Store RIM_Logo_small

Media Partnership:
Want to have your RSS feed integrated on our website? Contact us
RSS Feeds RSS Feeds
JoomlaWatch Stats 1.2.9 by Matej Koval
For Editors
Sign up for press releases
For Companies
Sign up for our newsletter

NiKem Research Receives Qualification for Bioanalysis of Clinical Samples

| Print |
Tuesday, 13 April 2010 14:00 (UTC + 2)


Baranzate, Italy, April, 13th 2010 / b3c newswire / - NiKem Research is pleased to announce that it has received on March 18th 2010, from the regional authority ASL Milano 1 of Regione Lombardia (Prot. N. 24588), the qualification to perform Pharmacokinetic, Metabolism and Bioequivalence analyses for clinical trials on healthy volunteers, according to Italian D.M. 19 March 1998. AIFA (Italian Medicines Agency) is now recording NiKem Research qualification.
This represents a further and exciting development of NiKem’s established preclinical GLP bioanalysis services.


NiKem Research has, for many years, provided high quality cost-effective bioanalytical support both for its in vitro ADME(T) and in vivo PK services associated to various drug discovery programs and as a standalone capability.  We are now able to offer our bioanalysis as a GLP service to not only support our clients preclinical PK and toxicology, but also our clients clinical studies.  Our new capability allows us to analyse biological samples from clinical studies to supply certified bioanalyses for:


• Method development and validation by HPLC-UV or UPLC/MS/MS;
• New Chemical Entity (NCE) Phase I studies on healthy volunteers;
• Clinical bioequivalence studies.


Giuseppe Giardina, CEO & Managing Director of NiKem, said “This new set of services is another important step in NiKem’s continuing expansion of its high quality and cost effective platform to support progression of our clients’ drug discovery programmes into the clinic”.


About NiKem Research - www.nikemresearch.com
Based on decades of drug discovery experience, NiKem Research offers a full range of Drug Discovery services to the pharmaceutical industry. In addition to its medicinal chemistry expertise in hit validation and multiparametric lead optimization, NiKem Research offers synthetic chemistry and parallel synthesis capabilities, computational and analytical chemistry services. Furthermore, ADMET profiling, biochemical pharmacology screening and in vivo PK services can be provided either as an integrated Drug Discovery platform or as individual service modules. NiKem Research usually operates as a fee-for-service partner although other business models can be used to ensure maximum value to our clients. All tangible and intangible assets generated during a collaboration are assigned to the client. www.nikemresearch.com


For more information please contact


Dr. Massimo Dondio
Director of Developability Sciences
NiKem Research s.r.l.
Tel. +39 02 35694 7460,
Fax +39 02 35694 7606
This e-mail address is being protected from spambots. You need JavaScript enabled to view it